MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME MONITOR

Catalog Number 07671687016

Device Problem High Test Results (2457)

Patient Problems Stroke/CVA (1770); Dizziness (2194)

Event Date 04/23/2022

Event Type  Injury  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The returned test strips were measured with the returned meter with a high level control sample.Testing results (qc range = 2.4 - 3.0 inr): qc measurement 1 = 2.8 inr.Qc measurement 2 = 2.7 inr.Qc measurement 3 = 2.8 inr.All inr values were within the specified target ranges and no error messages occurred.Upon review of the meter's patient result memory, the alleged value of "around 5" inr on 23-apr-2022 was not observed.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." medwatch field occupation the occupation is patient's wife.

Event Description

The patient's wife alleged that the patient received a questionable result when testing with coaguchek inrange meter serial number (b)(4).It was alleged the patient suffered a stroke approximately (b)(6)2022.Allegedly on (b)(6)2022, the patient tested on the meter and the result was "around 5" inr as reported by the patient's wife to one of the patient's physicians.The patient allegedly did not feel well and was dizzy.It was reported that the patient went to the hospital and the doctors said the patient had a stroke.Within 3 hours of the meter measurement, a sample from the patient was tested in the hospital laboratory using an unknown method, resulting in an alleged value of 3.8 inr.It was reported that the doctor concluded the meter was defective and prescribed another coaguchek device.The patient's therapeutic range is (b)(6).It was reported the patient has now returned home from the hospital without any after effects.The patient was reported to have been doing well and received aspirin treatment in addition to his warfarin treatment.Examples of information requested, but not provided at this time include patient details, including age, medical history, and medications taken.Diagnostic tests performed and results.The type of stroke (hemorrhagic or thromboembolic).Information on therapy provided to the patient at the hospital.Other inr measurements performed on the meter.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Evaluation method coding has been updated.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14497365
• MDR Text Key: 294663812
• Report Number: 1823260-2022-01480
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07671687016
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETYLLEUCINE; ASPIRIN; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Sex: Male